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avatrombopag

Small moleculeapprovedOrphan Drug FDA

Approved

May 21, 2018

Avatrombopag is an orally bioavailable, small molecule thrombopoietin (TPO) receptor agonist that stimulates proliferation and differentiation of megakaryocytes from bone marrow progenitor cells resulting in increased production of platelets. Avatrombopag does not compete with TPO for binding to the TPO receptor and has an additive effect with TPO on platelet production. Avatrombopag was discovered by Yamanouchi Pharmaceutical, developed by AkaRx which late became acquired by Dova Pharmaceuticals. In 2018 avatrombopag was approved by the FDA for thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure. — NCATS

Clinical trial activity

55 trials · 44 clinical orgs · 2 marketing orgs

Phase 1
11
Phase 2
27
Phase 3
15
Phase 4
8

Earliest trial started Feb 1, 2007 (NCT00441090)

Timeline

2000s

  1. Jan 1, 2007

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Earliest Phase 1 Sponsor(trial)

  2. Sep 1, 2011

    Orphan Drug Designation

  3. Jan 1, 2012

    Earliest Phase 3 Sponsor(trial)

  4. May 21, 2018

    AkaRx — Earliest FDA Approval

  5. May 21, 2018

    AkaRx — NDA Secondary Org

  6. May 21, 2018

    AkaRx — NDA Organization

  7. May 21, 2018

    Sarepta Therapeutics — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewMay 21, 2018

Chemistry & pharmacology

Loading structure…

SMILES

O=C(Nc1nc(-c2cc(Cl)cs2)c(N2CCN(C3CCCCC3)CC2)s1)c1cnc(N2CCC(C(=O)O)CC2)c(Cl)c1
Mol. weight
649.67 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 1-(3-chloro-5-((4-(4-chloro-2-thienyl)-5-(4-cyclohexylpiperazin-1-yl)thiazol-2-yl)carbamoyl)-2-pyridyl)piperidine-4-carboxylic acid
  • akr501
  • akr 501
  • akr-501
  • akr-501
  • akr-501
  • avatrombopag
  • avatrombopag
  • avatrombopag
  • avatrombopag
  • avatrombopag
  • avatrombopag maleate
  • avatrombopag maleate
  • avatrombopag maleate
  • e5501
  • e5501
  • e5501
  • e5501 compound
  • e5501 maleate
  • e5501 maleate
  • ym477
  • ym 477
  • ym-477

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07278908Phase 2/Phase 3 (Phase 3)Dec 31, 2025China Academy of Chinese Medical Sciences
NCT07051915Phase 3Sep 15, 2025Helse Fonna, Nordland Hospital, Northern Norway Regional Health Authority, Norwegian University of Science and Technology, Oslo Metropolitan University, Sorlandet Hospital HF, South-Eastern Norway Regional Health Authority, Sykehuset i Vestfold HF, University Hospital of North Norway, University of Bergen, University of Oslo, University of Stavanger
NCT07133659Phase 4Jun 8, 2025Al-Mustansiriyah University
NCT06202625Phase 2/Phase 3 (Phase 3)May 13, 2024Central South University, Harbin Medical University, Nanchang University, Peking University, People's Liberation Army of China, Shanxi Bethune Hospital, Sichuan University, Xinjiang Medical University, Zhengzhou University
NCT06281327Phase 2Mar 31, 2024China Academy of Chinese Medical Sciences, Henan Medical University, Kunming Medical University, Tianjin Medical University
NCT06254287Phase 2Feb 1, 2024China Academy of Chinese Medical Sciences
NCT05996393Phase 4Oct 31, 2023Chinese Academy of Medical Sciences
NCT05772546Phase 2Sep 30, 2023Harvard University, Swedish Orphan Biovitrum
NCT06004752Phase 2Aug 17, 2023Chinese Academy of Medical Sciences
NCT06001567Phase 2Aug 14, 2023Guangzhou Medical University
NCT05907499Phase 3Jul 1, 2023Soochow University
NCT05720234Phase 2Nov 10, 2022China Academy of Chinese Medical Sciences
NCT05571332N/AJun 28, 2022Chinese Academy of Medical Sciences
NCT05369208Phase 3Jun 15, 2022Swedish Orphan Biovitrum
NCT05433922N/AJun 1, 2022Chinese Academy of Medical Sciences
NCT05518331N/AJun 1, 2022China Academy of Chinese Medical Sciences, Chinese Academy of Medical Sciences, Harbin Medical University, Hebei University, Peking University, Shanxi Medical University
NCT05382013Phase 4Apr 27, 2022Sun Yat-Sen University
NCT05218226Phase 2Jan 25, 2022China Academy of Chinese Medical Sciences, Chinese Academy of Medical Sciences, Henan Medical University, Kunming Medical University, Tianjin Medical University
NCT05143892Phase 2/Phase 3 (Phase 3)Dec 1, 2021Soochow University
NCT05046327Phase 3Oct 14, 2021Dova Pharmaceuticals
Showing 20 of 55 trials
Page 1 / 3

Organizations

Research & Development (44)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
EisaiFor profit191932007
Chinese Academy of Medical SciencesAcademic/Hospital101042021
China Academy of Chinese Medical SciencesAcademic/Hospital6432022
Dova PharmaceuticalsFor profit6532018
Swedish Orphan BiovitrumFor profit3122020
Anhui Medical UniversityAcademic/Hospital2122020
Harbin Medical UniversityAcademic/Hospital2022022
Henan Medical UniversityAcademic/Hospital2012022
Kunming Medical UniversityAcademic/Hospital2012022
Nanchang UniversityAcademic/Hospital2022021
Peking UniversityAcademic/Hospital2122022
People's Liberation Army of ChinaGovernment2122021
Soochow UniversityAcademic/Hospital2212021
Sun Yat-Sen UniversityAcademic/Hospital2222021
Tianjin Medical UniversityAcademic/Hospital2012022
Al-Mustansiriyah UniversityAcademic/Hospital1112025
Central South UniversityAcademic/Hospital1012024
Guangzhou Medical UniversityAcademic/Hospital1112023
Harvard UniversityAcademic/Hospital1112023
Hebei UniversityAcademic/Hospital1012022
44 organizations
Page 1 / 3

Marketing (3)

OrganizationOrg typeRelationshipDate
AkaRxFor profitNDA2May 21, 2018
AkaRxFor profitNDAMay 21, 2018
Sarepta TherapeuticsFor profitNDA2May 21, 2018